Systems, methods and computer program products for providing compliant messaging services

ABSTRACT

Systems, methods and computer program products for providing compliant messaging services are disclosed. Methods according to some embodiments include receiving input data from a campaign sponsor, encrypting at least a portion of the input data, generating a message schedule that includes message content, recipient identification data and temporal data corresponding to a plurality of messages, and sending and/or receiving one of the plurality of messages to and/or from a corresponding recipient.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of Ser. No. 12/434,244,filed May 1, 2009, which is a is a non-provisional patent application,which claims the benefit of U.S. Provisional Application No. 61/051,447,filed on May 8, 2008, the entire contents of which are herebyincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to communication and, moreparticularly, to systems, methods and computer program products forproviding messaging services.

BACKGROUND

Many industries may utilize and/or rely on communications with multipleclasses of users. For example, the healthcare and pharmaceuticalindustries may rely on communications between various classes includinghealthcare providers, such as doctors and/or nurses, patients,prospective patients, and/or clients, such as, for example, healthcareresearch organizations, medical device manufacturers and/orpharmaceutical companies, among others. Advances in technology haveprovided for wireless communication systems using, for example, mobileterminals. However, such systems may not provide safeguards that may berequired under strictly regulated industries, such as, for example, thehealthcare and/or pharmaceutical industries. Accordingly, currentlyavailable systems and methods may not be suitable for use inapplications that require compliance with industry-specific rules andregulations.

SUMMARY

Pursuant to some embodiments of the present invention, systems, methodsand computer program products for providing compliant messaging servicesare disclosed. Some embodiments include methods of providing healthcarecompliant messaging services that include receiving input datacorresponding to a campaign from a campaign sponsor, encrypting at leasta portion of the input data, and generating, under the control of one ormore computer systems, a message schedule that is based on the inputdata and that includes message content, recipient identification dataand temporal data corresponding to multiple messages. Methods mayinclude sending one of the messages to a corresponding recipient,confirming a delivery of at least one of the messages sent to therecipient and receiving a response from the corresponding recipient tothe one of the messages. Methods may include validating at least one ofthe messages and/or the response from the corresponding recipient. Someembodiments provide that validating includes comparing the messagesand/or the response to multiple valid messages. Some embodiments includegenerating an audit trail that is configured to create a historicalrecord corresponding to each of the messages and generating a uniqueidentifier corresponding to the one of the messages.

Some embodiments of the present invention include methods for providingcompliant messaging services. Such methods may include receiving inputdata corresponding to a campaign from a campaign sponsor, encrypting atleast a portion of the input data, generating, under the control of oneor more computer systems, a message schedule that is based on the inputdata and that includes message content, recipient identification dataand temporal data corresponding to multiple messages. Some embodimentsinclude sending one of the messages to a corresponding recipient.

Some embodiments include confirming a delivery of at least one of themessages sent to the recipient. Some embodiments include validating atleast one of the messages and/or a response from the correspondingrecipient, wherein validating includes comparing the message and/orresponse to multiple valid messages.

Some embodiments include, upon receiving indication of delivery failureof the at least one of the messages, sending the at least one of themessages via a different redundant communication network route and/orchannel. In some embodiments, receiving indication of delivery failureof the at least one of the messages includes failure to confirm adelivery of the at least one of the messages. Some embodiments providethat receiving indication of delivery failure of the at least one of themessages includes receiving indication of delivery failure from acommunications network resource.

Some embodiments include generating an audit trail that is configured tocreate a historical record corresponding to each of the messages. Insome embodiments, the audit trail includes message version data, messagetimestamp data corresponding to any changes to the message, deliveryattempt data including corresponding timestamp data, response datacorresponding to messages received by compliant message module and/oruser identification data.

Some embodiments provide that the compliant messaging services arecompliant with healthcare and/or pharmaceutical service specificrequirements.

Some embodiments include receiving a response from the correspondingrecipient to the one of the plurality of messages. Some embodimentsinclude generating unique identifiers corresponding to ones of themessages.

Some embodiments of the present invention include a healthcare compliantmessage system for providing healthcare compliant messaging services.Embodiments of such a system include a campaign message manager thatreceives campaign data corresponding to a campaign by a campaign sponsorand subject data corresponding to study subjects who are participatingin the campaign, and generates message schedule data corresponding tothe campaign data and the subject data and that defines message deliveryand message content information. A system may include a compliantmessage module that receives the message schedule data, transmitsmessages that correspond to the message schedule to respective mobileterminals, and receives a message originating from at least one of themobile terminals responsive to the transmitted message.

In some embodiments, the compliant message module is further configuredto transmit a message to the mobile terminal that is responsive to amobile terminal originated message that is an initiating messageresponsive to an external information source.

Some embodiments provide that the campaign message manager includes auser interface that receives the campaign data via an administrativeuser, wherein the user interface includes an end user portion thatreceives the study data, and an enrollment module that uses subject datathat is received via the user interface to populate an enrolled studysubject database corresponding to enrolled study subjects. In someembodiments, the campaign message manager includes a message schedulegenerator that uses the campaign data via the user interface and theenrolled study subject database to generate message schedule data.

In some embodiments, the message schedule data includes at least onemessage schedule, message content, at least one reminder message, atleast one message language identifier, message format and/orlocation-based temporal information. Some embodiments provide that thecampaign message manager includes a communication module thatcommunicates message schedule data to the compliant message module.

In some embodiments, the compliant message module includes a messagetransmitter that transmits messages to at least one mobile terminalaccording to the message schedule, a message receiver that receivesmessages originated by at least one mobile terminal, and an audit trailmodule that generates and maintains an audit trail corresponding tomessages that are transmitted to the at least one mobile terminal andreceived by the compliant message module. Some embodiments provide thatthe audit trail includes message version data, message timestamp datacorresponding to any changes to the message, delivery attempt dataincluding corresponding timestamp data, response data corresponding tomessages received by compliant message module and/or user identificationdata.

Some embodiments include a validation module that is operable tovalidate received messages originated by the at least one mobileterminal to determine if ones of the received messages are validresponses to respective ones of the transmitted messages, wherein theaudit trail further includes validation data.

In some embodiments, the message schedule data includes a messagefrequency restriction corresponding to transmitted messages. Someembodiments provide that the message frequency restriction restricts thequantity of messages that can be transmitted within a defined temporalduration.

In some embodiments, the campaign message manager generates the messageschedule data via at least one message template that includes apredefined message format and wherein the campaign data includes atleast one message template identifier that corresponds to the at leastone message template. Some embodiments provide that the at least onemessage template includes a multilingual function such that at least onemessage template is operable to be expressed and/or receive data inmultiple languages. In some embodiments, the at least one messagetemplate includes multiple customizable placeholders.

Some embodiments include computer program products for providingcompliant messaging services, the computer program product comprising acomputer usable storage medium having computer readable program codeembodied in the medium, the computer readable program code configured tocarry out the methods described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram illustrating a system for providing compliantmessaging services according to some embodiments of the presentinvention.

FIG. 2 is a block diagram of a system for providing compliant messagingservices according to some embodiments of the present invention.

FIG. 3 is a block diagram illustrating operations for providingcompliant messaging services according to some embodiments of thepresent invention.

FIG. 4 is a block diagram illustrating a user interface according tosome embodiments of the present invention.

FIG. 5 is a block diagram illustrating operations for providingcompliant messaging services according to some embodiments of thepresent invention.

DETAILED DESCRIPTION

The present invention now is described more fully hereinafter withreference to the accompanying drawings, in which some embodiments of theinvention are shown. This invention may, however, be embodied in manydifferent forms and should not be construed as limited to theembodiments set forth herein; rather, these embodiments are provided sothat this disclosure will be thorough and complete, and will fullyconvey the scope of the invention to those skilled in the art.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. The terminology used in thedescription of the invention herein is for the purpose of describingparticular embodiments only and is not intended to be limiting of theinvention. As used in the description of the invention and the appendedclaims, the singular forms “a”, “an” and “the” are intended to includethe plural forms as well, unless the context clearly indicatesotherwise. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items.

Pursuant to embodiments of the present invention, systems and methodsare provided for providing compliant messaging services. Compliance maybe required for applications used in, for example, healthcare and/orpharmaceutical industries. In some embodiments, a sponsor, such as apharmaceutical provider, for example, may initiate and/or manage acampaign such as, for example, a clinical and/or marketing studyregarding a new drug and/or drug application and/or disease condition.In some embodiments, a campaign may include a prescription reminderservice. In this regard, a campaign may include a series of eventsand/or operations undertaken to achieve a specific goal. As describedherein, campaigns may be directed to gathering and/or disseminatinginformation and/or data corresponding to a clinical and/or marketingstudy regarding a new drug and/or drug application, disease conditionand/or a prescription reminder service, among others. Concomitant withsuch studies may be strict requirements including audit trails,validation, authentication and/or confidentiality, among others.Additionally, as a practical matter, global connectivity, sufficientencryption and performance, multi-lingual capability and/or integrationflexibility may be necessary as well. In this regard, a trusted thirdparty to manage the management, data, communications, and/or complianceissues associated with such campaigns may be beneficial. For example, insome regulatory environments, sponsors may be prohibited from havingdirect contact with and/or storing any customer, subject and/or patientdata, among others.

In some embodiments of the present invention, the compliant messagingservices disclosed herein may be utilized for subject recruitment forclinical studies. For example, prospective subjects may be pre-screenedvia responses to text messages including specific pre-screeningquestions. Such questions may include queries regarding age, gender,weight, height, non-smoker/smoker and/or ethnicity, among others. Inthis manner, only prospective study subjects meeting the initial studycriteria may be directed to contact a call center for additionalevaluation. Prospective candidates may be determined by health providerlists, and/or responses to advertisements among others. In someembodiments, a geographic location of a subject may be determined using,for example, a location identifier, such as a post code and/or a zipcode among others. Some embodiments provide that the geographic locationmay be used to direct a request to a locally proximate hospital, callcenter, and/or clinic, among others.

Reference is now made to FIG. 1, which is a block diagram illustrating asystem for providing compliant messaging services according to someembodiments of the present invention. A campaign message manager 100 maybe configured to include a user interface 102. The user interface 102may be configured to receive campaign data 10 from, for example, a studyadministrator who may be administering and/or managing a study orcampaign, a site administrator and/or a system administrator, amongothers. In some embodiments, a system administrator may input campaigndata 10 through an administrative interface portion that may be used forthe creation and setup of the study (campaign), the site, and/or theuser. In some embodiments, the campaign data 10 may be input manuallyand/or through a batch upload via the user interface 102.

In some embodiments, the user may include a doctor, nurse, patientand/or other client representative, among others. The user interface 102may also include an end user portion that may be used by the clientrepresentative to perform functions related to study subjects and/orschedules. In some embodiments, subjects may include patients in ahealthcare related campaign and/or study. In this regard, subject data20 may be received via the end user portion of the user interface 102.In some embodiments, the subject data 20 may be input manually and/orthrough a batch upload via the user interface 102.

In some embodiments, the campaign message manager 100 may include anenrollment module 104 that may use the subject data 20 received throughthe user interface 102 to populate a data base (not shown). Theenrollment module 104 may be used to capture and/or store subject dataincluding, for example, name, contact information, and/or study specificinformation, among others. In some embodiments, the enrollment module104 may provide a unique subject identifier that may be used to identifythe subject without compromising any of the subject's confidentialinformation.

Some embodiments provide that a message schedule generator 106 may beincluded to generate message schedules, message content, reminders,message language(s), message format, and/or communication protocol,among others. The message schedule generator 106 may use the campaigndata 10 and the subject data 20 to generate complete message scheduledata. Some embodiments provide that the message schedule generator 106generates message schedules according to one or more local time zones ofrespective recipients. A communication module 108 may be configured tocommunicate the message schedule data to a compliant message module 110that is configured to deliver and/or manage the delivery of the messagesin compliance with regulatory requirements. In some embodiments, themessage schedule data may include message content, delivery temporaldata, a subject identifier, message format and/or location-basedtemporal information (e.g., time zones), among others. Some embodimentsprovide that message data storage 109 is configured to store datacorresponding to messages that are scheduled by the message schedulegenerator 106 and/or communicated via the communication module 108. Insome embodiments, the message data storage 109 may be a portion of adata storage structure and/or device that is configured to store subjectdata 20 and/or campaign data 10.

The compliant message module 110 may include message data storage 112that is configured to receive and/or store the message data from thecampaign message manager 100. In some embodiments, the message datastorage 112 may operate in conjunction with an audit trail module 120that may be configured to generate and maintain an audit trail for allmessages. In some embodiments, the audit trail may include all versionsof a message including timestamp data corresponding to any changes,delivery attempt data including timestamps of all message deliveryattempts, response data corresponding to any responses, validation data,user name, and/or database changes, among others.

The message data storage 112 may be configured to operate in conjunctionwith an encryption module 122 that may be configured to provideencryption of message data and/or subject data 20 for transmissionand/or storage. For example, in some embodiments, phone numbers andmessages may be encrypted at the data storage level in a data structuresuch as, for example, a database.

The compliant message module 110 may include a message transmitter 114that is configured to transmit messages at times and dates correspondingto the message schedule. The message transmitter 114 may be configuredto operate using data communication standards including ExtensibleMarkup Language (XML) and/or Hypertext Transfer Protocol over SecureSocket Layer (HTTPS), among others. The message transmitter 114 may beconfigured to provide global interconnectivity using multiplecommunications networks worldwide. In some embodiments, the messagetransmitter 114 may include an architecture that processes more than 500messages per second in more than 200 countries via access to more than600 system operators. In some embodiments, the message transmitter 114may use open communications, network and/or device standards to reducerisks associated with integration complexity. In this manner, messagesmay be delivered to mobile terminals 50 in compliance with regulatoryrequirements.

In some embodiments, the message transmitter 114 may be configured toprovide redundant communications network paths to transmit messages tothe mobile terminal 50. For example, some embodiments provide that ifthe compliant message module 110 determines that the message was notreceived by the mobile terminal 50, then the message transmitter 114 mayresend the message to the mobile terminal 50 via another communicationsnetwork path and/or route. In this manner, the messaging services may beless susceptible to interruptions from communications network relatedoutages and/or performance issues. Some embodiments provide that thecompliant message module 110 may determine that the message was notreceived by the mobile terminal 50 based on a lack of confirmationreceipt. In some embodiments, the compliant message module 110 maydetermine that the message was not received by the mobile terminal 50based on information received from a communications network resource.

In some embodiments, a mobile terminal 50 may include a subject mobileterminal corresponding to a subject participating in a study. In someembodiments, a mobile terminal 50 may include a mobile terminalcorresponding to a provider, administrator and/or sponsor. Someembodiments provide that the mobile terminal 50 may include a personaldigital assistant (PDA), cell phone, pager and/or a machine that doesnot include a direct human communication interface. For example, themobile terminal 50 may include a machine such as a software and/orhardware device that is operable to monitor glucose, blood pressureand/or other physiological conditions that does not include a directhuman communication interface as may typically be found in a cell phone.In this regard, the mobile terminal 50 may be operable to trigger anevent on the machine and/or send/receive a message containing data fromand/or corresponding to the mobile terminal 50. In some embodiments, themobile terminal 50 may provide 2-way communication without a directhuman communication interface. For example, some embodiments providethat a physiological condition value range may be transmitted to themobile terminal 50 and, if a measured corresponding physiologicalcondition value is not within the range, an event may be triggered and acommunication may be transmitted by the mobile terminal 50.

The compliant message module 110 may include a response receiver 116that is configured to receive response messages that originate frommobile terminals 50. For example, in the case that a reminder messageregarding an upcoming appointment is transmitted to the mobile terminal50, a response might include a delivery confirmation indicating that themessage was received and/or an indication as to whether the subject willbe at the appointment. The compliant message module 110 may include avalidation module 118 that is configured to validate a response thatoriginates from a mobile terminal 50. For example, the content of avalid response may be specific to the sent message. In some embodiments,responding to a message may include initiating a logical responsesequence that is responsive to the content of a received message. Forexample, in some embodiments, email may be sent to a provider if asubject is unable to keep a scheduled appointment. In some embodiments,a text message may be sent back to a subject requesting additionalinformation and/or data. Some embodiments provide that the validationmodule 118 can accept or reject responses from the mobile terminal. Insome embodiments, the validation module 118 may prompt the mobileterminal 50 for a valid response. For example, when an invalid responseis received, the validation module 118 may prompt the mobile terminal 50for a valid response.

The validation module 118 and/or the response receiver 116 may beconfigured to transmit response data and/or validation data to messagedata storage 112. The response data may be maintained in the audit trailby virtue of the audit trail module 120. In some embodiments, theencryption module 122 may provide encryption for all or portions of theresponse data before storage.

Response data may be communicated from the compliant message module 110to the campaign message manager 100, which may be configured to storethe response data in the message data storage 109. In some embodiments,the transmitted message may be referred to as a mobile terminating (MT)message and the response message may be referred to as a mobileoriginating (MO) message. In some embodiments, the campaign messagemanager 100 may request that the compliant message module 110 providemessage delivery status regarding a MO and/or a MT message. Someembodiments provide that when confirmation of delivery of the MT messageis received, the MT message may be deleted from message data storage112. In some embodiments, regulatory requirements may dictate thatcaptured clinical data in a mobile terminal be deleted after theclinical data is transferred to the compliant message module 110.

In some embodiments, regulatory requirements may dictate that capturedclinical data may only reside in limited configurations. For example,regulations may require clinical data that is captured on a mobileterminal to be destroyed when the data is transferred to another datarepository. In some embodiments, a message may include a self-executingdelete function that may be initiated by temporal, access, and/ortransmission events. In this manner, a message may include aself-destruct feature to remove traces of the message when, for example,it is transmitted to and/or receipt is confirmed by another datarepository.

In some embodiments, any of a plurality of encryption schemes may beutilized to provide secure, encrypted messages. For example, someembodiments provide that a secure key may be provided to a mobile and/orother terminal for decrypting subsequent messages. In this manner,regulatory compliance directed to encryption requirements may beprovided.

In some embodiments, a MO message may indicate that an appointment needsto be rescheduled. In such cases, additional MT messages may begenerated responsive to this condition. In some embodiments, the subjectmay be directed to call a provider facility to reschedule theappointment. In some embodiments, the MT message may be a query as tohow a subject is feeling. A valid MO message responsive to such a querymay be limited to a finite set of responses, such as, for example,“Well”, “Poorly”, and/or “OK”, among others. Additionally, to accuratelyassociate a MO message to a specific MT message, the MT message mayinclude a study-specific and/or message-specific time-out functionand/or unique identifier. In some embodiments, the time-out function mayrecall the MT message if confirmation delivery is not received within acertain time from the transmission of the MT message. In someembodiments, the time-out function may trigger the compliant messagemodule 110 to resend the MT message one of more times.

As discussed herein, the compliant message module 110 may operate inconjunction with a campaign message manager 100. In some embodiments,the campaign message manager 100 may be implemented as a stand aloneapplication and/or in a dedicated server that is distinct fromoperations of study sponsors and/or clients. Some embodiments providethat the campaign message module 100 may be installed and/or hostedwithin a sponsor and/or client facility and/or equipment and be usedand/or administered on-site by sponsor and/or client personnel. However,embodiments herein are not so limited. For example, reference is nowmade to FIG. 2, which is a block diagram of a system for providingcompliant messaging services according to some embodiments of thepresent invention.

In some embodiments, the compliant message module 110 may operate incooperation with sponsor applications 150A-B associated with multipledifferent respective sponsors. In some embodiments, sponsor may includepharmaceutical manufacturers, wholesalers, retailers and/or distributorsand/or medical device manufacturers, wholesalers, retailers and/ordistributors. For example, a first sponsor application 150A maycorrespond to a pharmaceutical company that is sponsoring a campaign fora clinical study corresponding to one of their proposed, existing and/orhistorical pharmacological offerings. A second sponsor application 150Bmay correspond to a research clinic conducting a subject recruitmentcampaign for a planned clinical trial. In this regard, the compliantmessaging module 110 may provide the compliant messaging functions asdiscussed above regarding FIG. 1 associated with each of the twodifferent sponsor applications 150A-B.

Reference is now made to FIG. 3, which is a block diagram illustratingoperations for providing compliant messaging services according to someembodiments of the present invention. Input data is received from acampaign sponsor (block 140). In some embodiments, the input data mayinclude message data, subject data, campaign data, schedule data, logindata, client data, unique identifier, metadata and/or user data, amongothers. Operations include encrypting at least a portion of the inputdata (block 142). In some embodiments, encrypting includes encryptingdata prior to storage in a data storage structure, media and/or device.In some embodiments, encrypting includes encrypting a portion of thedata that includes message content.

Some embodiments include generating a message schedule that includesmessage content, recipient identification data and temporal datacorresponding to multiple messages (block 144). The message schedule mayinclude content, delivery times and delivery conditions corresponding toreminder messages, status request messages, and/or confirmationmessages, among others. For example, a subject may be sent a MT messageincluding a reminder of an upcoming appointment and/or a reminder totake a specific medication. In some embodiments, the MT message may seeka responsive MO message indicating a subject's status, such as, forexample, how the subject is feeling and/or whether the subject will beat a scheduled appointment, among others.

Some embodiments include sending one of the multiple messages to acorresponding recipient (block 146). In some embodiments, thecorresponding recipient may be a subject and/or potential subject of acampaign, such as a clinical study and/or a study recruiting campaign.Some embodiments may include confirming a delivery of at least one ofthe multiple messages. In some embodiments, the delivery confirmationand/or message content may be sent to the campaign sponsor and/ormaintained in a messaging service database. Some embodiments providethat delivery confirmation and/or message content may be provided and/orreported online via a network such as, for example, the Internet. Inthis manner, a sponsor may access delivery confirmation and/or contentin a convenient and/or secure manner. In some embodiments, a logicalsequence may be initiated responsive to the content of the MO messageand/or delivery confirmation.

Some embodiments may include, upon receiving indication of deliveryfailure of the at least one of the multiple messages, sending the atleast one of the multiple messages via a different redundantcommunication network route and/or channel. In some embodiments,receiving indication of delivery failure of the at least one of messagemay include a failure to confirm a delivery of the at least one message.For example, some embodiments provide that indication of deliveryfailure may be received from a communications network resource. In thismanner, redundant delivery paths may be provided to enhance thereliability of the messaging operations.

Some embodiments provide that a MT message may be responsive to anunprompted MO message. For example, an unprompted MO message maybeinitiated by a user responsive to, for example, an advertisement thatmay be received by the user via one or more advertising media such asmagazines, newspaper, television, internet and/or radio, among others.

Some embodiments include generating an audit trail that is configured tocreate a historical record corresponding to each of the messages. Insome embodiments, the audit trail may include a history that capturesall modifications, generation and/or transmissions of each messageand/or the timestamp corresponding to each of the activities, user nameand/or events. In some embodiments, the audit trail may include datathat is encrypted in compliance with regulatory requirements.

In some embodiments, the compliant messaging service may be configuredto comply with healthcare service specific requirements. For example,healthcare services may be regulated by codes and/or statutes includingthe Health Insurance Portability and Accountability Act (HIPPA) and/orrules promulgated by the Department of Health and Human Services (HHS).For example, HHS rules may include a privacy rule, which may establishregulations for the use and disclosure of Protected Health Information(PHI), and a security rule, which may deal specifically with ElectronicProtected Health Information (EPHI) and identify three types of securitysafeguards required for compliance, including, for example,administrative, physical, and/or technical safeguards. In someembodiments, healthcare services may be regulated by the Food and DrugAdministration via, for example, 21 C.F.R. § 11. Although discussed inthe context of healthcare specific services, however, the disclosureherein is not so limited.

Some embodiments include receiving a response from a subject via amobile terminal. As discussed above regarding FIG. 1, a MO message maybe received and may provide information responsive to the sent (MT)message. In some embodiments, at least one of the MT messages and/or MOmessages may be validated. Some embodiments provide that validation mayinclude comparing content in a MO to a set of valid response messages.In some embodiments, validation information may be stored and may beincluded in an audit trail.

Some embodiments may include generating and assigning unique identifiersfor campaigns, studies, clients, users, potential subjects, subjects,message recipients, and/or messages, among others. In some embodiments,unique identifiers can be used to query delivery receipts and/or MOresponses to delete specific messages and/or to update specificmessages. In some embodiments, unique identifiers may be used to match aMT message with a MO message that is received. In some embodiments,identifiers, input data, message schedule data, sent messages, deliveryconfirmations, received messages, and/or audit trail data may be storedin a data base and may be selectively encrypted therein. Someembodiments provide that messages may be transmitted and/or received inmultiple languages and that services may be globally provided usingtelecommunications operators in a multiple different foreign countries.

Reference is now made to FIG. 4, which is a block diagram illustrating auser interface 160 according to some embodiments of the presentinvention. In some embodiments, the user interface 160 may include alogin screen 161 that may be configured to permit selective levels ofsystem access to authorized users. A login screen 161 may include fieldsto enter a site destination, a user login name and/or a password amongothers. In some embodiments, the login screen 161 may be configured toprovide a limited number of login attempts before preventing access fora given user.

In some embodiments, a user interface 160 may include a study set-upscreen 162. Some embodiments provide that a study set-up screen 162 mayinclude entry fields for providing a study name, a program code, and/ora status that is configured to indicate whether the study is in a liveor test mode. In some embodiments, the study set-up screen 162 may beconfigured to receive subject identifier format information, such aslength and/or alpha-numeric content format, email subject data, emailsender data, study graphical representations, such as, for example, alogo, and additional notes and/or help text. In some embodiments, astudy set-up screen 162 may include one or more fields corresponding toa specific graphic and/or group of graphical properties that maycorrespond to, for example, a theme of a client and/or user. Althoughillustrated herein as a single study set-up screen 162, some embodimentsprovide that the study set-up screen 162, as well as other screensdisclosed herein, may include multiple screens that may be usedcollectively to receive, display, evaluate and/or edit data.

In some embodiments, message templates may be available for a user toselect. Message templates may include preconfigured messages and/ormessage formats that may be populated with user and/or sponsor-specificdata. Some embodiments provide that the message templates and the userand/or sponsor-specific data may be provided in a message data storagedevice. In some embodiments, the message template may be stored in themessage data storage and the user and/or sponsor-specific data may bereceived from a user and/or sponsor-controlled storage device such thatthe messages are dynamically generated before transmission. Someembodiments provide that a message template can be associated with amessage template identifier that may be used to specify which of aplurality of message templates is to be used.

In some embodiments, a message template may include a multilingualfunction. For example, the message template may be operable to beexpressed in one or more of multiple different languages. Someembodiments provide that a message template may include multiplecustomizable placeholders. In some embodiments, the multiplecustomizable placeholders may include a subject identifier, a nurse'sname, and/or a doctor's name, among others.

In some embodiments, a user interface 160 may include an event messagescreen 163 that may include entry fields for entering, editing and/ordeleting messages. Some embodiments provide that the event messagescreen 163 may display, for at least a portion of the messages, relevantdata such as, for example, message name, message type, message content,message template and/or template identifier, and/or text, message timingrelative to events, a transmission time, and/or recipient data and/orclass, among others. In some embodiments, the message content mayinclude text and/or graphical data, including, for example, barcodes,uniform resource locators (URL's), multimedia messaging service (MMS)messages, and/or other media capable of being delivered via mobilecommunications devices. Some embodiments provide that the messagecontent may be provided in MO and/or MT messages.

In some embodiments, a user interface 160 may include a response messagescreen 164 that includes entry fields for entering, editing and/ordeleting MT messages that are responsive to MO messages. Someembodiments provide that the response message screen 164 may display,for at least a portion of the messages, relevant data including the nameof the MT message that the MO message was responsive to, when theresponsive MO message is received, the content of the responsive MTmessage, the recipient data and/or class, the name of the responsive MTmessage, and/or the type of responsive MT message, among others.

In some embodiments, the user interface 160 may include an events screen165 that may include entry fields corresponding to an event schedulebased on client and/or sponsor requirements. In this regard, an eventschedule may be generated that relates the messages to specific events.Some embodiments provide that the first event may be a baseline event,which may be used to automatically generate other event dates usingrelative temporal parameters that may be entered in the events screen165. In some embodiments, event information including an event number,an event name, event timing, a schedule deviation tolerance value,message delivery options, and/or save and/or display options, amongothers, may be displayed, entered, edited and/or deleted for each event.Some embodiments provide that the events screen 165 may providetolerance ranges corresponding to the event schedule to provide thatmessages may be sent in compliance with a study protocol. In someembodiments, the tolerance ranges may correspond to a preferred messageschedule that may be defined by, for example, a sponsor, user and/orsubject, among others.

In some embodiments, the user interface 160 may include a site set-upscreen 166 that is configured to receive data and/or informationregarding a hospital/clinic (in the case of a healthcare relatedcampaign), and/or other facility and/or any other location including,for example, a specific country. The site set-up screen 166 may be usedto enter information including date format, time zone, and/or messagetranslations, among others. In some embodiments, a site may beconfigured to include more than one language. The site set-up screen 166may provide for multiple selections corresponding to the site. Someembodiments provide that information corresponding to site messages maybe entered, displayed and/or edited including site number, date format,time zone, language(s), campaign name, message name, message contentand/or text, a time-out duration value, time-out units, invalid text,one or more valid responses, number of valid attempts, and/or responsetriggers, among others. In this manner, for each campaign, messages maybe sent via a variety of networks that may vary by country, region, siteand/or location. In some embodiments, campaigns may include multipledifferent communication modes including, but not limited to, one and/ortwo way messaging, among others, that may be country, region, siteand/or location specific. In some embodiments, the message translationsmay include placeholders and/or custom fields such as event date and/orthe subject identifier, among others to provide a personalized message.

In some embodiments, the user interface 160 may include a subjectenrollment screen 167. The subject enrollment screen 167 may includefields for entering, editing and/or deleting information regardingenrollment of a subject. Although not illustrated herein, someembodiments may include a subject withdrawal screen and/or a subjectinformation editing screen. Some embodiments provide that a subjectidentifier and subject contact information, such as, for example, aphone number and/or email address may be entered. In some embodiments,the first event, which may be the baseline event may be displayed and/oredited. Some embodiments provide that other events that may bedetermined as a function of the first event may be displayed and/oredited. In this manner, the subject enrollment screen 167 may provideflexibility regarding specific subject requirements, preferences and/orlimitations. The subject enrollment screen 167 may provide multipleselection language selections, medication dosages, medication types,diagnosis, and/or prescription refill quantities, among others, thathave been specified in the site set-up screen 166. In some embodiments,a subject may access the subject enrollment screen 167 to perform aself-enrollment.

Reference is now made to FIG. 5, which is a block diagram illustratingoperations for providing healthcare compliant messaging servicesaccording to some embodiments of the present invention. The functionsaccording to blocks 140-146 are discussed above regarding FIG. 3 and arenot repeated herein. Methods may further include confirming a deliveryof at least one of the multiple messages (block 148). In someembodiments, the delivery confirmation and/or message content may besent to the campaign sponsor and/or maintained in a messaging servicedatabase. Some embodiments provide that delivery confirmation and/ormessage content may be provided and/or reported online via a networksuch as, for example, the Internet. In this manner, a sponsor may accessdelivery confirmation and/or content in a convenient and/or securemanner. In some embodiments, a logical sequence may be initiatedresponsive to the content of the MO message and/or deliveryconfirmation.

Some embodiments include receiving a response from the recipient (block150). For example, a MO message may be sent in response to a MT message.Some embodiments may include validating at least one of the MT messagesand/or MO messages (block 152). Some embodiments provide that validatingmay include comparing content in a MO to a set of valid responsemessages.

Some embodiments include generating an audit trail that is configured toprovide a historical record corresponding to ones of the MT and/or MOmessages (block 154). In some embodiments, validation information may bestored and may be included in an audit trail. In some embodiments, theaudit trail may include a history that captures all modifications,generation and/or transmissions of each message and/or the timestampcorresponding to each of the activities, user name and/or events. Insome embodiments, the audit trail may include data that is encrypted incompliance with regulatory requirements.

Embodiments may include generating a message identifier corresponding toones of the MO and/or MT messages (block 156).

Some embodiments provide that a MT message may be responsive to anunprompted MO message. For example, an unprompted MO message maybeinitiated by a user responsive to, for example, an advertisement thatmay be received by the user via one or more advertising media such asmagazines, newspaper, television, internet and/or radio, among others.

Some embodiments provide that a MT message may be resent if a responsiveMO message is not received within a user-defined time period. In someembodiments, where the MT messages are sent in a broadcast set ofmessages, the broadcast set of messages may be adjusted to preventresending a message to a recipient that did respond.

In some embodiments, the compliant messaging service may be configuredto comply with healthcare service specific requirements. For example,healthcare services may be regulated by codes and/or statutes includingthe Health Insurance Portability and Accountability Act (HIPPA) and/orrules promulgated by the Department of Health and Human Services (HHS).For example, HHS rules may include a privacy rule, which may establishregulations for the use and disclosure of Protected Health Information(PHI), and a security rule, which may deal specifically with ElectronicProtected Health Information (EPHI) and identify three types of securitysafeguards required for compliance, including, for example,administrative, physical, and/or technical safeguards. In someembodiments, healthcare services may be regulated by the Food and DrugAdministration via, for example, 21 C.F.R. § 11. Although discussed inthe context of healthcare specific services, however, the disclosureherein is not so limited.

Some embodiments include receiving a response from a subject via amobile terminal. As discussed above regarding FIG. 1, a MO message maybe received and may provide information responsive to the sent (MT)message. In some embodiments, at least one of the MT messages and/or MOmessages may be validated. Some embodiments provide that validation mayinclude comparing content in a MO to a set of valid response messages.In some embodiments, validation information may be stored and may beincluded in an audit trail.

Some embodiments may include generating and assigning unique identifiersfor campaigns, studies, clients, users, potential subjects, subjects,message recipients, and/or messages, among others. In some embodiments,unique identifiers can be used to query delivery receipts and/or MOresponses to delete specific messages and/or to update specificmessages. In some embodiments, unique identifiers may be used to match aMT message with a MO message that is received. In some embodiments,identifiers, input data, message schedule data, sent messages, deliveryconfirmations, received messages, and/or audit trail data may be storedin a data base and may be selectively encrypted therein. Someembodiments provide that messages may be transmitted and/or received inmultiple languages and that services may be globally provided usingredundant telecommunications operators in a multiple different foreigncountries.

In the drawings and specification, there have been disclosed typicalembodiments of the invention and, although specific terms are employed,they are used in a generic and descriptive sense only and not forpurposes of limitation, the scope of the invention being set forth inthe following claims. Moreover, those skilled in the art will readilyappreciate that many modifications are possible to the exemplaryembodiments that are described in detail in the present specificationthat do not materially depart from the novel teachings and advantages ofthis invention. Accordingly, all such modifications are intended to beincluded within the scope of this invention as defined in the claims andequivalents thereof.

1. (canceled)
 2. A method for providing compliant messaging services,the method comprising: receiving input data corresponding to a campaignfrom a campaign sponsor; encrypting at least a portion of the inputdata; generating, under control of one or more computer systems, amessage schedule that is based on the input data, wherein the messageschedule comprises message content, recipient identification data ortemporal data; and sending, based on the message schedule, a message toa recipient.
 3. The method according to claim 2, further comprisingconfirming a delivery of the message sent to the recipient. 4.(canceled)
 5. (canceled)
 6. (canceled)
 7. The method according to claim2, further comprising validating the message or a response from therecipient.
 8. The method according to claim 2, further comprisinggenerating an audit trail that is configured to create a historicalrecord corresponding to the message.
 9. The method according to claim 8,wherein the audit trail includes message version data corresponding tothe message, message timestamp data corresponding to any changes to themessage, delivery attempt data including corresponding timestamp data,response data or user identification data.
 10. (canceled)
 11. The methodaccording to claim 2, further comprising receiving a response from therecipient.
 12. The method according to claim 2, further comprisingreceiving a response to the message, wherein the response is sent by amobile terminal without input via a direct human communicationinterface.
 13. A computer program product for providing compliantmessaging services, the computer program product comprising anon-transitory computer usable storage medium having computer readableprogram code embodied in the medium, the computer readable program codeconfigured to: receive, from a campaign sponsor, input datacorresponding to a campaign; encrypt at least a portion of the inputdata; generate, under the control of one or more computer systems, amessage schedule that is based on the input data, wherein the messageschedule comprises message content, recipient identification data ortemporal data; and send, over a communications network based on themessage schedule, a message to a recipient mobile terminal.
 14. Ahealthcare compliant message system for providing healthcare compliantmessaging services, the system comprising: a campaign message managerthat a. receives: i. campaign data from a campaign sponsor and ii.subject data, wherein the subject data corresponds to study subjects whoare participating in the campaign, and b. generates, based on thecampaign data and the subject data, message schedule data; and a firstset of one or more processors configured to: (a) receive the messageschedule data, (b) transmit, based on the message schedule data, amessage to a mobile terminal using a message transmitter, and (c)receive a message originating from the mobile terminal responsive to thetransmitted message.
 15. (canceled)
 16. The system according to claim14, wherein the campaign message manager comprises: a user interfacethat receives the campaign data via an administrative user, wherein theuser interface comprises an end user portion that receives the studydata; a set of one or more processors configured to: use subject datathat is received via the user interface to populate an enrolled studysubject database corresponding to enrolled study subjects; and a messageschedule generator that uses the campaign data via the user interfaceand the enrolled study subject database to generate message scheduledata.
 17. The system according to claim 16, wherein the message scheduledata includes at least one message schedule, message content, at leastone reminder message, at least one message language identifier, messageformat or location-based temporal information.
 18. The system accordingto claim 16, wherein the campaign message manager further comprises aset of one or more processors that is configured to communicate messageschedule data to the first set of one or more processors.
 19. The systemaccording to claim 14, wherein the message transmitter transmitsmessages to at least one mobile terminal according to the messageschedule; and the first set of one or more processors is furtherconfigured to receive messages originated by at least one mobileterminal.
 20. (canceled)
 21. The system according to claim 19, furthercomprising a set of one or more processors that is configured to:validate a received message originated by the at least one mobileterminal.
 22. The system according to claim 14, wherein the messageschedule data includes a message frequency restriction.
 23. The systemaccording to claim 22, wherein the message frequency restrictionrestricts a quantity of messages that can be transmitted within adefined temporal duration.
 24. (canceled)
 25. (canceled)
 26. (canceled)27. The method of claim 7, wherein validating comprises comparing themessage or the response from the recipient to a valid message.
 28. Thecomputer program product of claim 13, wherein the computer readableprogram code is further configured to receive a response to the messagefrom the recipient mobile terminal.
 29. The computer program product ofclaim 13, wherein the computer readable program code is furtherconfigured to generate an audit trail that is configured to create ahistorical record corresponding to the message.